A Recent Update on Indian Regulatory and Approval Guidelines of Radiopharmaceuticals for Clinical Applications

Radiopharmaceuticals play a crucial role in the applications of theranostics. Their use is strictly regulated In India by the Atomic Energy Regulatory Board (AERB) and the Central Standard Drug Control Organization (CDSCO). With advancements in nuclear medicines globally, India's regulatory framework needs to strengthen with regulatory bodies harmonized with global standards, including Good Manufacturing Practices (GMP), Good Regulatory Practices (GRP), Good Laboratory Practices (GLP), Declaration of Helsinki, etc. The increasing use of artificial intelligence in radiopharmaceuticals demands considerable up-gradation in the existing regulatory framework. This review critically analyses the current regulatory framework and guidelines for the clinical use and evaluation of radiopharmaceuticals. Also, it highlights the modern collaborative approach to dealing with the challenges of radiopharmaceuticals in India.